Roche Holding AG, the world’s leader in oncology drugs, struck an upbeat tone about approval prospects for its key drug Avastin in ovarian cancer ahead of an important industry meeting next month.
The group’s pharma head Pascal Soriot told reporters on Thursday he was confident Avastin will gain European approval and he was also relatively optimistic about winning U.S. backing for the drug.
“In Europe ... we are pretty confident because typically in Europe you can gain approval on the basis of good progression-free survival data,” Soriot said.
“In the U.S., we still have to wait until the data are fully mature to see what the overall survival data look like and get a good sense for the FDA’s response, but I have to say that what we have seen so far ... is making us relatively optimistic that we have a good chance in the U.S. as well,” he said.
Demand for Avastin, used to treat a range of tumors, has fallen over recent quarters after the drug was hit by moves from healthcare authorities on both sides of the Atlantic to curb its use in breast cancer.
Roche is now banking on the use of the multibillion dollar seller to treat ovarian cancer to drive future sales growth and is planning to file for approval in the United States later this year once it has overall survival data. It has already filed for approval in Europe.
“We will demonstrate Avastin has a critical role to play in ovarian cancer,” Soriot said ahead of the American Society of Clinical Oncology (ASCO) conference early next month in Chicago.
“All in all stunning new data showing our pipeline is progressing. Hopefully the turning point in the perception of Avastin,” Soriot said, referring also to the data on lung and skin cancer drugs that will be presented at ASCO.
Roche will present mid-stage data on MetMAb in lung cancer and it is aiming to file this treatment for approval in 2014, Soriot said, adding Roche was also looking at developing the drug in other diseases such as breast cancer.
Physicians and investors will also eye studies on vemurafenib, a drug to treat the deadliest form of skin cancer.
Soriot said the commercial opportunity of vemurafenib was limited in metastatic skin cancer due to the smaller number of patients in this setting, but there would be more potential sales if it were to be developed in the adjuvant setting.
The group has yet to decide on the pricing of the treatment and as a result does not yet have a peak sales estimate for it.
Roche’s drug, which it is developing with privately held Plexxikon, and ipilimumab, an experimental drug being developed by U.S. group Bristol-Myers Squibb, are giving hope to patients who previously had few treatment options.
Soriot said there was a place for both agents and he expects vemurafenib to establish itself as the first line of treatment in patients that are BRAF positive.
“Ipilimumab is a different agent. It is a compound that relies on the immune system to address the cancer. It is a drug that potentially can be given to all patients, whereas vemurafenib can only be given to those patients who are BRAF positive, which is about 50 percent of melanoma cancer patients,” Soriot said.
“It is important to keep in mind that the percentage of patients who really respond well to ipilimumab is relatively limited. Those patients have a strong response, but it is a small percentage, probably 10 percent of patients, who respond,” he said.
By Katie Reid